A Randomized, Cross Over Study Evaluating the Effect of Flovent Discus 100 Mcg BID vs QVAR 80 Mcg BID vs Pulmicort Flexhaler 180 Mcg BID on Short Term Growth in Pediatric Subjects With Asthma
| City: |
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Greentree |
| State: |
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Pennsylvania |
| Zip Code: |
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15220 |
| Conditions: |
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Asthma |
| Purpose: |
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Children with mild persistent asthma that have asthma symptoms once or twice a week and use
a daily controller, while children with mild intermittent asthma rarely have asthma symptoms
and do not use a daily controller. Inhaled corticosteroids are the standard treatment for
mild peristent asthma. The purpose of this study is to measure children rate of growth
while on different inhaled corticosteroids.
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| Study Summary: |
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A randomized, cross over study evaluating the effect of Flovent Discus 100 mcg BID vs QVAR
80 mcg BID vs Pulmicort Flexhaler 180 mcg BID on short term growth in pediatric subjects
with asthma.
Objectives:
1. The primary objective of this study is to compare the effect of Flovent Diskus 100 mcg
BID versus Pulmicort Flexhaler 180 mcg BID on short-term lower leg growth velocity as
measured by knemometry in pediatric subjects with mild asthma.
2. The secondary objective of this study is to compare the effect of Flovent Diskus 100
mcg BID versus QVAR 80 mcg BID on short-term lower leg growth velocity as measured by
knemometry in pediatric subjects with mild asthma.
Aims:
1. The primary aim is to show that there is a growth suppressive effect of Pulmicort
Flexhaler 180 mcg BID versus Flovent Diskus 100 mcg BID in children with mild asthma.
2. The secondary aim to show that there is a growth suppressive effect of QVAR 80 mcg BID
versus Flovent Diskus 100 mcg BID in children with mild asthma.
Hypotheses:
1. The primary hypothesis is that treatment with Pulmicort Flexhaler 180mcg BID as
compared to Flovent Diskus 100 mcg BID has a growth suppressive effect on lower leg
length as assessed by knemometry in pediatric subjects with mild asthma.
2. The secondary hypothesis is that treatment with QVAR 80 mcg BID as compared to Flovent
Diskus 100 mcg BID has a growth suppressive effect on lower leg length as assessed by
knemometry in pediatric subjects with mild asthma.
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| Criteria: |
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Inclusion Criteria:
1. Subjects will include females (6 to 9 years of age) and males (6 to 11 years of age).
2. All subjects must have a history of physician diagnosed mild intermittent or mild
persistent asthma as documented by PCP medical record or detailed history by study
investigator.
3. All subjects must have a height within normal limits (5th to 95th percentile) and no
history of abnormal growth as assessed by medical history.
4. All subjects must be pre-pubertal (Tanner Stage 1 Sexual Maturity) as assessed by
physical examination.
5. Subjects may be on current treatment with montelukast as this drug does not affect
growth. If a subject is on montelukast at screening/baseline, they will remain on a
stable dose throughout the study.
6. Subjects must be willing to comply with study requirements.
Exclusion Criteria:
1. Subjects will be excluded if they have asthma greater than mild persistent severity
as defined by NHLBI guidelines.
2. Subjects will be excluded if they used any systemic or nasal steroids within the past
60 days.
3. Subjects will be excluded if they had more than one burst of systemic steroids within
the past year.
4. Subjects will be excluded if their baseline FEV1 is < 80% predicted.
5. Subjects will be excluded if they have any other serious systemic disease other than
asthma.
6. Subjects will be excluded if they have taken any medication known to affect growth
i.e. ADHD medications within the past 60 days
7. Subjects will be excluded if they have a history of allergy to any of the study
medications, milk protein or lactose.
8. Subjects will be excluded if they have active chickenpox or measles or recent
exposure to chickenpox or measles.
9. Subjects will be excluded if they have any history of tuberculosis of the respiratory
tract.
10. Subjects will be excluded if they have any active fungal, bacterial, viral or
parasitic infections.
11. Subjects will be excluded if they have any history of herpes simplex infection of the
eye.
12. Subjects will be excluded if they have taken any immunosuppressive drugs within the
past 2 months.
13. Subjects will be excluded if they have any history of Churg-Strauss syndrome or other
eosinophilic disorders.
14. Subjects will be excluded if an investigator deems they have any mental or
development health issues, such as autism, moderate to severe mental retardation or
severe ADHD,that interferes with their ability to complete the knemometry
measurements.
15. Subjects will be excluded if an investigator deems they have any physical issues,
such as inability to sit independently or amputation of lower leg, that interferes
with their ability to complete the knemometry measurements.
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| NCT ID: |
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NCT01520688 |
| Primary Contact: |
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Principal Investigator
Deborah A Gentile, MD
Allegheny Singer Research Institute/Allegheny General Hospital
Deborah A Gentile, MD
Phone: 412-359-6645
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| Backup Contact: |
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Joseph Arcari, DO
Phone: 412-922-5250
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| Location Contact: |
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Greentree, Pennsylvania 15220
United States
Joseph Aracri, DO
Phone: 412-922-5250
Email: aracrij@pediatricalliance.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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